Pending Policies - Surgery


Image Guidance Surgery (IGS) System

Number:SUR701.019

Effective Date:04-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Image-guidance surgery (IGS) systems (i.e., InstaTrak™, Vectorvision iPlan™, StealthStation™, Stryker Navigation System™), and other like systems may be considered medically necessary for:

Intracranial procedures (excluding routine shunt procedures),

Cervical spinal surgery when screws and/or other hardware are applied to the cervical spine,

Lumbar and thoracic spinal surgery when pedicle screws and/or other hardware are applied under the following conditions:

1. Deformity of spine involving multiple levels; or

2. Altered spinal anatomy due to previous surgery or trauma,

The following sinus and skull base surgical procedures:

1. Revision sinus surgery;

2. Distorted sinus anatomy of development, postoperative, or traumatic origin;

3. Extensive sino-nasal polyposis;

4. Pathology involving the frontal, posterior ethmoid or sphenoid sinuses;

5. Disease abutting the skull base, orbit, optic nerve or carotid artery;

6. Cerebral spinal fluid (CSF) rhinorrhea or conditions where there is a skull base defect; or

7. Benign and malignant sino-nasal neoplasms.

IGS for all other sinus or skull base surgical procedures is considered not medically necessary.

IGS for indications other than those noted above is considered experimental, investigational and/or unproven.

Description:

Image-guidance surgery (IGS) systems are designed for use in sinus, spine, cranial, and skull base surgery. An IGS system combines a high-speed computer system and specialized software and tracking technology. Actual movements of surgical instruments are correlated to the patient’s preoperative medical images such as CT (computed tomography) or MRI (magnetic resonance imaging) and displayed on this computerized system’s display monitor.

IGS systems allow the surgeon to view 3-D images of the patient’s anatomy in response to the mouse or the tracked surgical instrument and manipulate the 3-D view in real time during the surgery. It is intended as an adjunct to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MRI, or X-ray.

Regulatory Status

The GE Medical Systems Navigation and Visualization Multiple Dataset Navigation option on the InstaTrak™ system is substantially equivalent to the Image Composer application on the Vectorvision iPlan™, manufactured by BrainLAB, and the StealthStation™ with StealthMerge application manufactured by Medtronic. Each of these devices also offers the capability to fuse multiple data sets from different imaging modalities. The GE Medical Systems Multiple Dataset Navigation application with InstaTrak™ has the same intended use and utilizes images from the same modalities as these devices.

Rationale:

This policy was originally developed in 2005 and has been updated with searches of scientific literature through March 2017. This section of the current policy has been substantially revised. The following is a summary of the key literature to date.

Scientific literature review has demonstrated that IGS systems can assist the surgeon by confirming position within challenging anatomical fields, identifying borders and achieving greater surgical accuracy which in turn improves patient outcomes. Studies have shown the value of IGS to be that of an important adjunctive tool in selected cases of advanced sinus surgery, intracranial surgeries, and pedicle screw placement in the cervical spine.

Intracranial Applications:

IGS are widely used in intracranial surgery. The imaging capability creates a 3-D reconstruction of the patient’s skull and brain. The system provides safer and less invasive access to brain tumors, vascular abnormalities and other intracranial targets. The greatest application of the IGS system is in anatomic navigation around tumor margins and determining regional anatomy. The surgeon can navigate precisely to the tumor while avoiding sensible structures. The depth of the tumor can be mapped, as well as critical structures that might lie on the other side of the resection plane. Such navigation increases the precision of the procedure, and can increase the speed at which surgery can be performed.

Sinus and Skull Base Applications:

IGS is an important adjunctive tool in selected cases of advanced sinus surgery. Studies have shown that IGS can assist the endoscopic sinus surgeon to confirm positioning of difficult anatomical fields. IGS surgery has not been proven as the standard of care for routine endoscopic sinus surgery. (9, 10, 11, and 12)

The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) endorses the use of computer-aided (i.e., image-guided) surgery in selected cases, in order to assist the surgeon in localizing anatomical structures and increasing patient safety.

The AAO-HNS examples of indications in which use of image-guidance sinus surgery may be appropriate include the following:

Revision sinus surgery,

Distorted sinus anatomy of developmental, postoperative, disease or traumatic origin,

Extensive sino-nasal polyposis,

Pathology involving the frontal, posterior ethmoid, or sphenoid sinuses,

CSF rhinorrhea or conditions where a skull base defect exists,

Benign and malignant sino-nasal neoplasms.

The AAO-HNS notes that computer-aided (image-guided) surgery provides 3-D real-time positioning within the nasal cavity and paranasal sinuses, allowing the surgeon to appropriately remove diseased tissue and avoid damage to the orbital, other extra-cranial and/or intra-cranial areas. This is particularly useful in patients who have experienced a loss of surgical landmarks and barriers due to previous surgery, sinonasal polyposis, neoplasms, or severe infections/inflammatory processes. The purpose of using stereotactic computer-assisted navigation in sinus surgery is to maximize accuracy and safety of the surgical procedure.

Spinal Applications:

Reports and studies note a benefit from image-guidance spinal surgery. IGS for spinal surgical procedures is currently widely accepted for intracranial procedures as well. There are important applications for IGS in the cervical spine. Typical examples include pedicle screw fixation to treat traumatic injuries (placement of C1-C2 transarticular screws where there is a significant risk of vertebral artery injury if the trajectory of the screws is not carefully planned), and the resection of certain spinal tumors and vascular malformations. In the case of unilateral or bilateral locked facets, several reports have demonstrated the benefits of traction and closed reduction followed by cervical pedicle screw fixation. (7, 8)

Placement of pedicle screws in the thoracic and lumbar spine has also been aided by image-guided navigation. Potential future applications of image-guidance spinal surgery include the ability to register transcutaneously, which could facilitate minimally invasive, percutaneous image-guidance spinal surgery. Basic anatomical knowledge and skill that surgeons need to perform demanding spinal procedures is not supplanted by IGS. It does, however, provide an added element of confidence, particularly when position and accuracy are critical. Like any new technique, incorporation of IGS into a surgeon’s collection requires patience and dedication. The advantages of image-guidance spinal surgery for appropriately selected cases could be substantial.

In an ECRI 2013 Product Brief: “The O-arm Surgical Imaging System [Medtronic, Inc.] for Two-dimensional and Three-dimensional Intraoperative Imaging during Orthopedic Procedures”: The evidence from review of abstracts of 13 published clinical studies suggested that the O-arm Surgical Imaging Systems works as indicated for placing orthopedic implants, especially pedicle screws, and these studies suggest that the accuracy of pedicle screw placement using the O-arm Surgical Imaging System may be better than standard C-arm fluoroscopy. Evidence from this review of abstracts of five clinical studies of radiation exposure suggests that the O-arm Surgical Imaging System, when used properly, does not expose the surgeon or patient to unnecessary radiation risk. (13)

A systematic review of all available prospective evidence regarding pedicle screw insertion techniques in the thoracic and lumbar human spine was conducted in 2012 (15). All prospective in vivo clinical studies in the English literature that assessed the results of different pedicle screw placement techniques (free-hand technique, fluoroscopy guided, computed tomography (CT)-based navigation, fluoro-based navigation) were considered. Twenty six prospective clinical studies were included in the analysis. These studies included in total 1,105 patients in which 6,617 screws were inserted. In the studies using free-hand technique, the percentage of the screws fully contained in the pedicle ranged from 69 to 94%, with the aid of fluoroscopy from 28 to 85%, using CT navigation from 89 to 100% and using fluoroscopy-based navigation from 81 to 92%. The screws positioned with free-hand technique tended to perforate the cortex medially, whereas the screws placed with CT navigation guidance seemed to perforate more often laterally. The conclusion of the study noted that navigation does indeed exhibit higher accuracy and increased safety in pedicle screw placement than free-hand technique and use of fluoroscopy.

In a 2014 Review published in the World Journal of Orthopedics, the author notes: “There are many published studies evaluating the use of free-hand technique, fluoroscopy-guidance, and stereotactic navigation in placing thoracolumbar pedicle screws. Between studies, assessment of screw accuracy varies significantly, which adds difficulty when interpreting and comparing them. Screws placed in the mid-thoracic spine and/or in spines with significant deformity should be guided stereotactically to ensure accuracy”. “Usage of image-guided techniques has clear benefits due to improved pedicle visualization. However, it may not be needed and might ultimately result in an added hindrance that can be avoided with free-hand pedicle screw placement without endangering the patient. The benefits and disadvantages of each technique must be appropriately weighed on a patient-by-patient basis in order to establish the best possible treatment strategy that both limits morbidity and ensures positive patient outcomes. Ultimately, it is the surgeon’s experience with a particular screw technique that determines his or her ability to accurately place pedicle screws.” (16)

2017 Update

A search of peer reviewed literature through March 2017 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

61781, 61782, 61783

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. U.S. Food and Drug Administration (FDA). Summary of safety and effectiveness. StealthStation System-FluoroNav Module™. 4/22/99.

2. Uddin, F.J., Sama, A., et al, Three-dimensional computer-aided endoscopic sinus surgery. Journal of Laryngology Otology. (2003 May) 117(5):333-9.

3. Tabee, A., Kacker, A., et al, Outcome of computer-assisted sinus surgery: a 5-year study, American Journal of Rhinology. (2003 Sep-Oct): 17(5):291-7.

4. U.S. Food and Drug Administration (FDA), Department of Health and Human Services, 501K Summary, K040050, Insta Trak™ 3500 Plus with Multiple Dataset Navigation, 4/24/2004.

5. U.S. Food and Drug Administration (FDA). 510(k)s Final decisions rendered for March 2000. Visualization Technology, Inc. InstaTrak 3000 System with Fluorotrak Module. 3/9/2004.

6. Kingdom, T.T., Orlandi, R.R., Image-guided surgery of the sinuses: current technology and applications. Otolaryngology Clinical North America. (2004 April) 37(2):381-400.

7. Issada, T., Hoang, L., et al. Minimally Invasive Spinal Surgery: A Historical Perspective. Neurosurg Focus. (2004 April 4) 16(1).

8. Seller, K., Wild, A., et al. Prospective screw misplacement analysis after conventional and navigated pedicle screw implantation. Biomed Tech (2005) 50(9):287-92.

9. American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS). AAO-HNS policy on intra-operative use of computer-aided surgery. Approved (Revised 3/2/2014). Last accessed October 2014. Available at <www.entlink.net>.

10. Johnson, J. P., King, W.A., et al. Computer-guided Endoscopic Neurosurgery in the Thoracic Spine. US Neurosurgical Disease (2006):56-8.

11. Fried, M, Parikh, S. et al. Image-Guidance for Endoscopic Sinus Surgery. The Laryngoscope Volume 118, Issue 7, pages 1287–1292, July 2008. Accessed December 2010.

12. Dalgorf DM, Sacks R, Wormald PJ, Naidoo Y, Panizza B, Uren B, Brown C, Curotta J, Snidvongs K, Harvey RJ. Image-guided surgery influences perioperative morbidity from endoscopic sinus surgery: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2013 Jul; 149(1):17-29.

13. American Medical Association. CPT Changes 2011. 2010; Chicago, IL; 2011; pp. 98-101

14. ECRI 2013 Product Brief: The O-arm Surgical Imaging System [Medtronic, Inc.] for Two-dimensional and Three-dimensional Intraoperative Imaging during Orthopedic Procedures. Accessed November 2014.

15. Gelalis ID1, Paschos NK et al., Accuracy of pedicle screw placement: a systematic review of prospective in vivo studies comparing free hand, fluoroscopy guidance and navigation techniques. Eur Spine J. 2012 Feb; 21(2):247-55.

16. Varun P., Jason A, et al. Techniques and accuracy of thoracolumbar pedicle screw placement. World J Orthop 2014 April 18; 5(2): 112-123

Policy History:

Date Reason
4/15/2018 Reviewed. No changes.
6/1/2017 Document updated with literature review. Coverage unchanged.
4/15/2016 Reviewed. No changes.
2/1/2015 Document updated with literature review. The following was added to the medically necessary conditional coverage criteria: 1) Coverage changed for sinus and skull base surgical procedures to note the current guidelines from The American Academy of Otolaryngology (AAO-HNS) – for Head and Neck Surgery, and 2) Addition of the following coverage statement: Lumbar and thoracic spinal surgery when pedicle screws and/or other hardware are applied under the following conditions: deformity of spine involving multiple levels; or altered spinal anatomy due to previous surgery or trauma.
2/1/2011 Document updated with literature review. Coverage unchanged. This document is no longer scheduled for routine literature review and update.
11/15/2008 Revised/updated entire document
12/1/2006 Revised/updated entire document
5/5/2005 Revised/updated entire document
3/1/2005 New medical document

Archived Document(s):

Title:Effective Date:End Date:
Image Guidance Surgery (IGS) System06-01-201704-14-2018
Image Guidance Surgery (IGS) System04-15-201605-31-2017
Image Guidance Surgery (IGS) System02-01-201504-14-2016
Image Guidance Surgery (IGS) System02-01-201101-31-2015
Image Guidance Surgery (IGS) System11-15-200801-31-2011
Image Guidance Surgery (IGS) System12-01-200611-14-2008
Image Guidance Surgery (IGS) System05-05-200511-30-2006
Image Guidance Surgery (IGS) System03-01-200505-04-2005
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